Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial

Abstract

Objective: To evaluate risankizumab, a biological therapy that inhibits interleukin 23, in patients with active psoriatic arthritis (PsA) who have responded inadequately or are intolerant to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD).

Methods: In the randomised, placebo-controlled, double-blind KEEPsAKE 1 trial, 964 patients with active PsA were randomised (1:1) to receive risankizumab 150 mg or placebo at weeks 0, 4 and 16. The primary endpoint was the proportion of patients achieving ≥20% improvement in American College of Rheumatology criteria (ACR20) at week 24. Here, we report the results from the 24-week double-blind period; the open-label period with all patients receiving risankizumab is ongoing.

Results: At week 24, a significantly greater proportion of patients receiving risankizumab achieved the primary endpoint of ACR20 (57.3% vs placebo, 33.5%; p<0.001). Significant differences were also observed for risankizumab versus placebo for the first eight ranked secondary endpoints, including skin and nail psoriasis endpoints, minimal disease activity and resolution of enthesitis and dactylitis (p<0.001). Adverse events and serious adverse events were reported at similar rates in the risankizumab and placebo groups. Serious infections were reported for 1.0% and 1.2% of patients receiving risankizumab and placebo, respectively. There was one death in the risankizumab group (urosepsis deemed unrelated to the study drug).

Conclusions: Risankizumab treatment results in significantly greater improvement of signs and symptoms of PsA compared with placebo and is well tolerated in patients with active PsA who have responded inadequately or are intolerant to ≥1 csDMARD.

Trial registration number: NCT03675308.

Keywords: arthritis; biological therapy; psoriatic.

Conflict of interest statement

Competing interests: LEK has received honoraria or fees for serving as a speaker or consultant from AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Gilead, Janssen, Lilly, Merck, Novartis, Pfizer and UCB. He has received investigator-initiated study grants from AbbVie, Biogen, Janssen, Lilly, Novartis, Pfizer and UCB. MK has received honoraria or fees for serving on advisory boards, as a speaker or as a consultant, and has received grants as a principal investigator from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Novartis, Pfizer, Roche and UCB. KP has received honoraria or fees for serving on advisory boards, as a speaker and as a consultant, as well as grants as principal investigator from AbbVie, Amgen, Astellas, Bausch Health (Valeant), Baxalta, Baxter, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Coherus, Dermira, EMD Serono, Forward Pharma, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa Kirin, LEO Pharma, Lilly, MedImmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Stiefel, Sun Pharma, Takeda and UCB. LM has received fees for serving on an advisory board from Lilly. DW has received honoraria or fees for serving on advisory boards, as a speaker and as a consultant, from AbbVie and Novartis. WL, ZW, AMS, AE and LB are full-time employees of AbbVie and may hold AbbVie stock or stock options. AMS is listed as an inventor on some AbbVie patents. FB has received research grants, honoraria or fees for serving as a consultant or speaker from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Chugai, Galapagos, Genzyme, Gilead, GlaxoSmithKline, Janssen, Lilly, Merck, Novartis, Pfizer, Roche and Sanofi.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Patient disposition. PBO, placebo; RZB, risankizumab.

Figure 2

ACR responses over time. (A) ACR20, (B) ACR50 and (C) ACR70 response rates for risankizumab 150 mg and placebo over the 24-week, double-blind treatment period. ACR20/50/70, ≥20%/50%/70% improvement in American College of Rheumatology score; PBO, placebo; RZB, risankizumab. ***P≤0.001 versus PBO. $Statistically significant under overall type I error control. **P≤0.01.

Figure 3

PASI 90 response over time. Among patients with ≥3% body surface area affected by psoriasis at baseline. PASI 90, ≥90% reduction in Psoriasis Area and Severity Index; PBO, placebo; RZB, risankizumab. ***P≤0.001 versus PBO. $Statistically significant under overall type I error control.